Spots Global Cancer Trial Database for A Dose-Ranging Study of IV BNZ-1 in LGL Leukemia or Refractory CTCL

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Trial Identification

Brief Title: A Dose-Ranging Study of IV BNZ-1 in LGL Leukemia or Refractory CTCL

Official Title: A Dose-Ranging Study of Intravenous BNZ132-1-40 in Patients With Large Granular Lymphocyte Leukemia or Refractory Cutaneous T-Cell Lymphoma

Study ID: NCT03239392

Conditions

LGL Leukemia

CTCL

Interventions

BNZ132-1-40

Study Description

Brief Summary: This study is an open-label, multi-center, dose-ranging study to characterize the safety, tolerability, preliminary efficacy, and PK/PD of up to four dose levels of BNZ-1 administered weekly by IV infusion to adults diagnosed with Large Granular Lymphocyte (LGL) Leukemia or refractory Cutaneous T-cell Lymphoma (CTCL).

Detailed Description: This study is an open-label, multi-center, dose-ranging study to characterize the safety, tolerability, preliminary efficacy, and PK/PD of up to four dose levels of BNZ-1 administered weekly by IV infusion to adults diagnosed with LGL or CTCL. The study has 5 periods: * Screening Period * 4-week Treatment Period * 3-month Treatment Extension Period * Long-term Extension Period (open-ended) * 6-week Follow-up Period Subjects will be screened for eligibility within 30 days of study Day 1 (first dosing day of the 4-Week Treatment Period).